- Olympus Corporation of the Americas (Center Valley, PA)
- …an entity other than @Olympus.com, it is likely not legitimate._ **Job Description** The Global Regulatory Affairs Operations Manager, is responsible for ... objectives. The Operations Manager will work directly with the VP of Global Regulatory Affairs Operations to ensure the smooth and efficient delivery… more
- Merck (North Wales, PA)
- …the Business Continuity Standards and Training (BCST) group within the Global Regulatory Affairs Clinical Safety (GRACS) Operations , Process & Systems ... across GRACS. Final External Policy is the official approved version of regulatory requirements or expectations that have undergone a thorough review, consultation,… more
- Merck (North Wales, PA)
- **Job Description** Our Diagnostics focused Regulatory Affairs team helps bring new precision medicine advancements to the world by facilitating effective, ... as appropriate, and corresponding therapeutic dossiers. + Interacting with global regulatory authorities and diagnostic partners to...devices, the majority of which must be in diagnostic regulatory affairs . Preferred: MS with minimum of… more
- Merck (North Wales, PA)
- …innovative products and services that save and improve lives around the world. The Global Regulatory Affairs and Clinical Safety (GRACS) Quality and ... Compliance (Q&C) team builds trust and confidence with global health authorities by instituting solid & robust processes...& robust processes and systems that adhere to a regulatory quality & compliance framework. The GRACS Quality and… more
- Philips (Pittsburgh, PA)
- …right fit if:** + You have a minimum of 10 years' experience working in Regulatory Affairs and Quality/Quality Operations within the FDA regulated Medical ... The Director of Regulatory Affairs & Quality will lead...and/or Quality teams. + You have extensive experience/knowledge of global medical device regulations, requirements, and standards (ISO 13485,… more
- CSL Behring (King Of Prussia, PA)
- …manufacture and commercial launch. Interface with other disciplines including Global Regulatory Affairs , Project Management, Operations and Commercial ... is responsible for the leadership and co-ordination of all regulatory GxP inspections for the R&D teams and across...Pharmacovigilance and Safety. Responsible for the execution of the global audit program for R&D, including internal systems and… more
- Bausch + Lomb (Harrisburg, PA)
- …the future. **Objectives** A member of the global technical CMC team for global regulatory CMC strategy for submissions and content of CMC dossiers for ... interdisciplinary project teams and to appropriate management level in Regulatory Affairs , R&D, TechOps and Supply Chain...documents in accordance with project timeline. + Coordinate with Regulatory Operations to ensure timely and accurate… more
- Organon & Co. (Plymouth Meeting, PA)
- …agile manner. + Provide Regulatory CMC and oversight in developing global Regulatory CMC strategies and executing submissions related to diverse late-stage ... **The Position** Reporting to the Director or Executive Director in Organon Regulatory CMC New Products, the Associate Principal Scientist (Associate Director) is… more
- Merck (North Wales, PA)
- …standards and policies and business objectives. Actively participate in labeling and global regulatory team meetings to ensure support for anticipated ... all US promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to...your employment may pose an undue burden to business operations , in which case you may not be offered… more
- J&J Family of Companies (Horsham, PA)
- …partners with individuals in Gastroenterology TA and other groups inside and outside Medical Affairs (eg Biostats, GCO, Regulatory Affairs , QA and QC) to ... with other GI team members in the US and Global Medical Affairs Organization, as well as...matrix clinical trial teams and external investigators/KOLs on study operations and provide program leadership and medical oversight. *… more
- Sumitomo Pharma (Harrisburg, PA)
- …Ltd. is a global pharmaceutical company based in Japan with key operations in the US (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and ... with the US Field Medical team, Medical Communications & Operations , Japan medical affairs colleagues, RWE (Real...global pharmaceutical company based in Japan with key operations in the US (Sumitomo Pharma America, Inc.), Canada… more
- Bausch + Lomb (Harrisburg, PA)
- …**Contacts (Internal And** **External)** + **Internal:** US Medical Affairs , Regulatory Affairs , Clinical Operations , Research & Development/Life Cycle ... Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and...eye health in the future. **Position** **Summary** The Medical Affairs Director provides support to the Medical Affairs… more
- Merck (North Wales, PA)
- **Job Description** **2025 US Medical Affairs Health Systems Oncology Internship** The Future Talent Program features internships that last up to 12 weeks and will ... Development Division is currently recruiting for a summer intern for the US Medical Affairs Health Systems Oncology (HSO) team. The intern in this position will gain… more
- West Pharmaceutical Services (Exton, PA)
- …Project Management (RPM) role is responsible for management of regulatory affairs projects associated with West's global portfolio of medical devices, ... quality assurance, clinical affairs , labeling, to align on deliverables for global submissions, establish key regulatory positions, and to ensure product… more
- J&J Family of Companies (Spring House, PA)
- …closely with the Global Regulatory Leader (GRL) and partners across Global Regulatory Affairs as well as Project Management, Medical Writing, ... playbooks, scenario evaluation and business case development). + Lead operations with Global Regulatory Team...and lifecycle documents) is required. + Demonstrated understanding of Global Regulatory Affairs processes is… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …Serves as a principal assistant to the Global Head of Legal - Regulatory , Quality, Medical & Scientific Affairs . Responsible for management of the delivery ... operations and functional areas for Medical & Scientific Affairs (MSA) and Quality Assurance & Regulatory ...by the Global Head of Legal - Regulatory , Quality, Medical & Scientific Affairs , including… more
- Merck (North Wales, PA)
- …see if we are the right company for your long-term goals **Team Overview:** The Global Regulatory Affairs and Clinical Safety (GRACS) Regulatory Digital ... facilitating communications and procedures that allow swift, organized compliance across regulatory agencies. We are an international network on the leading-edge of… more
- Takeda Pharmaceuticals (Harrisburg, PA)
- …+ Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies for assigned ... + Working within Labeling Team and GRA + Represents Global Labeling at Global Regulatory ...Regulatory Team (GRT) + Liaises with US Labeling Operations , EU Labeling Operations , Labeling Devices Lead… more
- Merck (North Wales, PA)
- …Scientific Leaders; and ensure all Scientific Leader engagement activities comply with regulatory , legal, and ethical standards + Commercial lead in driving engaging ... Vaccines Franchise brands at Congresses; identifying strategic congresses for Global support, including key regional congresses, aligning team activities, and… more
- Pfizer (Collegeville, PA)
- …In collaboration with Scientific Affairs (SA) Biostatistics group and Clinical Affairs (CA) Operations , the CS is responsible for execution and project ... the CS will lead via a matrix organization Epidemiology, Biostats, Clinical Operations , Medical/Scientific Affairs , Regional, Pfizer laboratory assay group, and… more